from Plastic Surgery News
The Food and Drug Administration (FDA) on March 9 approved a silicone gel-filled breast implant manufactured by Sientra Inc., to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes.
“The ability to offer our patients a wider variety of treatment options is good for everyone,” says ASPS President Malcolm Z. Roth, MD. “Innovation and patient safety drive our specialty, so we welcome the opportunity to provide yet another FDA-approved alternative for both breast augmentation and reconstruction patients.” Read more…